To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM
Recruiting · NCT06293417 · Interventional (participants receive a specific treatment) · Lead sponsor: Korea University Anam Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Dose escalation of moderate-intensity statinEzetimibe/fenofibrate (Ezefeno) and moderate-intensity statin
What this trial is about
The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: * major adverse cardiovascular events within 48 months of the trial duration * microvascular events within 48 months of the trial duration
Who can take part
Age range
19 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
- Age ≥ 19 years
- Non-HDL-C ≥100 mg/dL, TG ≥200, \<500 mg/dL on moderate-intensity statins
- with cardiovascular risk factor
Exclusion criteria
- Pregnant or breastfeeding women
- Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
- Patient with myopathy and rhabdomyolysis
- AST/ALT more than 3 ULN
- Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption
Where it is running
1 location listed.
- Korea University Anam Hospital - Seoul, South Korea